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NCT Number: NCT03755193

Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:

SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months

Recruiting

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

20 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

Location status: Recruiting

Location contact

Yukio Nakamura, MD, PhD

CONTACT

[email protected]

+81-263-37-2659

Yukio Nakamura, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • osteoporosis patients

Exclusion criteria

  • not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant

Treatment and study plan

SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"

Drug

To examine the effects of SERM and ELD in osteoporosis patients

Bisphosphonates and ELD "Edirol®Tablet 0.75ug"

Drug

To examine the effects of BP and ELD in osteoporosis patients

ELD "Edirol®Tablet 0.75ug"

Drug

To examine the effects of ELD in osteoporosis patients

Primary outcomes

  1. Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone

    Time frame: Change from Baseline Values of bone mineral density at 2 years in each group

Study contacts

Contact information is provided by the study sponsor or research team.

Yukio Nakamura

CONTACT

[email protected]

+81263372576

Sponsors and collaborators

Lead sponsor

Shinshu University

Other

Registry information

Official study title

Examination of Efficacy and Safety of SERM or Bisphosphonates After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Nov 27, 2018
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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